Safety and Tolerability of Epinastine HCl 0.05% Ophthalmic Solution in Healthy Adults

Abstract

Abstract: : Purpose: This single-center, randomized, double-masked study evaluated the safety and tolerability of epinastine ophthalmic solution in healthy adults Methods: Subjects were randomly assigned to receive epinastine HCl 0.05% (n=120) or vehicle (n=60) administered 1 drop in both eyes for 6 weeks. Biomicroscopy before and after instillation and visual acuity examinations were conducted at 4 study visits on days 0 (baseline), 7, 21, and 42. Intraocular pressure (IOP) measurements and pre-instillation ophthalmoscopic examinations were conducted on days 0 and 42. Results: Mean age of participants was 41.0 years (range 18-77); 40.6% were male and 59.4% female. No clinically or statistically significant differences in frequencies of adverse events (AEs) overall or of any individual adverse event were observed between treatment groups. AEs were reported in 15.8% of epinastine subjects and 25% of vehicle subjects. Infection, primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects. There was a significantly lower frequency of ocular AEs in the epinastine group compared to the vehicle group, 1.7% vs. 11.7% respectively (P=0.007). No significant differences were observed between groups in pre-instillation biomicroscopy findings relative to baseline, or in comparisons of pre-instillation with post-instillation biomicroscopy findings. No significant between group differences in IOP, visual acuity, or ophthalmoscopy were observed. Conclusions: Epinastine 0.05% ophthalmic solution instilled BID for 6 weeks was safe and well-tolerated by healthy adults.

Keywords: clinical (human) or epidemiologic studies: tre • drug toxicity/drug effects • pharmacology